Extractables, Leachables, & Elemental Impurities 2017

Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics
October 24–25, Sheraton La Jolla, CA

Featuring Lessons Learned and Case Studies from Industry Experts:
  • A Discussion of USP Chapters <665> and <1665> Dealing with Materials and Components Used in Pharmaceutical Manufacturing Systems
    • Dennis Jenke, Triad Scientific Solutions
  • Updates & Case Studies on the Latest Compliance Implications of USP <232> and <233> and ICH Q3D Risk Assessment Filing Guidelines for Elemental Impurities
    • Timothy Shelbourn, Research Scientist, Eli Lilly & Co.
    • Smriti Khera, Agilent Technologies
    • Diego Zurbriggen, West Pharmaceutical Services
  • The Risk Assessment of Extractables — A Toxicological Window of Opportunity
    • William P. Beierschmitt, Research Fellow, Pfizer
  • BPOG’s Leachables Best Practice Guide: Study Design and Analytical Methods
    • Laszlo Litauski, Assoc. Director, Shire
  • Challenges & Consequences for the Medical Device Industry by the Revision of Three Major ISO 10993-Standards
    • Dr. Albrecht Poth, Senior Toxicologist, Dr. Knoell Consult GmbH


24 October 2017 to 25 October 2017
La Jolla, California, US